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October 13, 2025
Medtronic’s Endurant Stent Graft System’s rAAA Labeling Updated by FDA
October 13, 2025—Medtronic announced that the FDA has approved new labeling for the company’s Endurant stent graft system for use in the treatment of ruptured abdominal aortic aneurysms (rAAA), removing the previous rAAA treatment warning.
The device, which is designed for endovascular aneurysm repair, is supported by extensive clinical evidence across elective and emergent use cases, noted the company.
According to Medtronic, this approval aligns regulatory labeling with current real-world endovascular practices. The company noted that the labeling update comes after an FDA review of international real-world data evaluating endovascular devices used in emergent rAAA repair.
“This landmark effort harnessed international, real-world data to evaluate the performance of endovascular devices in the treatment of rAAAs,” commented Adam Beck, MD, in Medtronic’s press release.
Dr. Beck, who is Director of the Division of Vascular Surgery and Endovascular Therapy at the University of Alabama in Birmingham, Alabama, continued, “The recent FDA labeling approval provides physicians with confidence in an endovascular treatment option for rAAA patients for the first time.”
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